MAUDE Adverse Event Report: BAYER PHARMA AG ESSURE; TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Model Number ESS305

Device Problems Separation Failure (2547); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 11/03/2015

Event Type  Injury  

Event Description

This spontaneous case was reported by a gynecologist and describes the occurrence of pelvic pain ("complaining of pelvic pain since the insertion") in a (b)(6) female patient who had essure (batch no.C68117) inserted.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device deployment issue "release difficulty (implant release problem)" on (b)(6) 2015.On (b)(6) 2015, the patient had essure inserted.On (b)(6) 2015, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required) and fatigue ("fatigue").In (b)(6) 2015, the patient experienced musculoskeletal pain ("left scapular pain"), gastrointestinal pain ("painful digestive disorders"), abdominal distension ("bloating"), constipation ("constipation"), the first episode of paraesthesia ("extremities paraesthesia (problems with her extremities)") and asthenia ("asthenia").In 2016, the patient experienced polymenorrhoea ("short menstrual cycles (3 weeks) for the last 4 months").On an unknown date, the patient experienced menorrhagia ("one episode of menorrhagia"), the second episode of paraesthesia ("paresthesia of the left shoulder with tendonitis"), rotator cuff syndrome ("paresthesia of the left shoulder with tendonitis"), headache ("unusual headaches"), back pain ("lumbar pain") and libido decreased ("high decrease of libido").The patient was treated with surgery (essure removal).Essure was removed.At the time of the report, the pelvic pain, menorrhagia, fatigue, the last episode of paraesthesia, rotator cuff syndrome, headache, back pain and libido decreased outcome was unknown and the musculoskeletal pain, gastrointestinal pain, abdominal distension, constipation, asthenia and polymenorrhoea had not resolved.The reporter provided no causality assessment for abdominal distension, asthenia, back pain, constipation, fatigue, gastrointestinal pain, headache, libido decreased, menorrhagia, musculoskeletal pain, pelvic pain, polymenorrhoea, rotator cuff syndrome, the first episode of paraesthesia and the second episode of paraesthesia with essure.The reporter commented: underwent direct hysteroscopic insertion of essure implants without anesthesia according to the usual procedure on (b)(6) 2015 the procedure took place with an implant release problem and the follow-up examination confirmed the presence of two implants in place.Three weeks after the placement of essure, the patient experienced atypical symptoms with progressive worsening.Diagnostic results (normal ranges are provided in parenthesis if available): abdominal x-ray - on (b)(6) 2016: "cofirmed" success of placement.Allergy test - on (b)(6) 2017: patch tests for chromium, cobalt and nickel negative at 72 hours.Gynaecological examination - on (b)(6) 2017: no effusion, inserts well placed; on an unknown date: implants in place, abdomen soft with no guarding, fallopian tubes and ovaries normal, no intraperitoneal effusion, uterus unremarkable.Testing for biological inflammatory syndrome, result not provided.Quality-safety evaluation of ptc: detachment difficulty is defined as a failure of the micro-insert to detach (separate) from the delivery system.Under normal circumstances, when the physician completes all deployment steps in the lfu, the micro-insert will detach from the delivery wire and remain in the fallopian tube.Several factors can contribute to a detachment difficulty event.The most likely root causes are tubal spasms which can clamp down on the distal end of the catheter and prevent the micro-insert from releasing from the delivery wire, stretching of micro-insert during placement attempts which tightens the inserts grip on the delivery wire, repositioning of the catheter after the first rollback and button press are completed which can also tighten the inserts grip on the delivery wire, and potential manufacturing deficiencies.Sample not available.We conducted a review of the manufacturing batch record and confirmed that final product testing for this lot was performed per requirements and the product met all release requirements.We are unable to confirm any quality defect or device malfunction at this time.Although we were unable to confirm this complaint, we cannot exclude the possibility of having a technical issue involved in the complaint.The possibility of micro-insert breaking is an anticipated event and there was no event reported which indicates a new technical failure mode for the device.Based on the provided information the defect type corresponds to the following meddra llt: device deployment issue.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events cannot be totally excluded.The reported medical events are not indicative of a quality deficit per se.A review of similar cases for this batch resulted in no unusual pattern identified.Most recent follow-up information incorporated above includes: on 13-dec-2018: (b)(4) was identified as a duplicate of this case.The following medical information was transferred from case (b)(4) into this case as a follow-up ¿ new reporter (healthcare professional); essure removal (case upgraded to incident); and new adverse events (paresthesia of the left shoulder with tendonitis, unusual headaches, lumbar pain and high decrease of libido).Incident: we received a lot number/returned sample in this case.A technical investigation will be conducted, including a batch review, and a review of complaint records and other non-conformances data; should any new and reportable information become available as a result, this will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was reported by a gynecologist and describes the occurrence of pelvic pain ("complaining of pelvic pain since the insertion") in a 34-year-old female patient who had essure (batch no: c68117) inserted.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device deployment issue "release difficulty (implant release problem)" on (b)(6) 2015.On (b)(6) 2015, the patient had essure inserted.On (b)(6) 2015, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required) and fatigue ("fatigue").In november 2015, the patient experienced musculoskeletal pain ("left scapular pain"), gastrointestinal pain ("painful digestive disorders"), abdominal distension ("bloating"), constipation ("constipation"), the first episode of paraesthesia ("extremities paraesthesia (problems with her extremities)") and asthenia ("asthenia").In 2016, the patient experienced polymenorrhoea ("short menstrual cycles (3 weeks) for the last 4 months").On an unknown date, the patient experienced menorrhagia ("one episode of menorrhagia"), the second episode of paraesthesia ("paresthesia of the left shoulder with tendonitis"), rotator cuff syndrome ("paresthesia of the left shoulder with tendonitis"), headache ("unusual headaches"), back pain ("lumbar pain") and libido decreased ("high decrease of libido").The patient was treated with surgery (essure removal).Essure was removed.At the time of the report, the pelvic pain, menorrhagia, fatigue, the last episode of paraesthesia, rotator cuff syndrome, headache, back pain and libido decreased outcome was unknown and the musculoskeletal pain, gastrointestinal pain, abdominal distension, constipation, asthenia and polymenorrhoea had not resolved.The reporter provided no causality assessment for abdominal distension, asthenia, back pain, constipation, fatigue, gastrointestinal pain, headache, libido decreased, menorrhagia, musculoskeletal pain, pelvic pain, polymenorrhoea, rotator cuff syndrome, the first episode of paraesthesia and the second episode of paraesthesia with essure.The reporter commented: underwent direct hysteroscopic insertion of essure implants without anesthesia according to the usual procedure on 3-nov-2015 the procedure took place with an implant release problem and the follow-up examination confirmed the presence of two implants in place.Three weeks after the placement of essure, the patient experienced atypical symptoms with progressive worsening.Diagnostic results (normal ranges are provided in parenthesis if available): abdominal x-ray: on (b)(6) 2016: cofirmed success of placement.Allergy test: on (b)(6) 2017: patch tests for chromium, cobalt and nickel negative at 72 hours.Gynaecological examination: on (b)(6) 2017: no effusion, inserts well placed; on an unknown date: implants in place, abdomen soft with no guarding, fallopian tubes and ovaries normal, no intraperitoneal effusion, uterus unremarkable.Testing for biological inflammatory syndrome, result not provided.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 8-jan-2019: quality safety evaluation of ptc (updated).Incident: we received a lot number/returned sample in this case.A technical investigation will be conducted, including a batch review, and a review of complaint records and other non-conformances data; should any new and reportable information become available as a result, this will be provided in a supplementary report.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• MDR Report Key: 8184155
• MDR Text Key: 130991106
• Report Number: 2951250-2018-05183
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• Combination Product (y/n): N
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 01/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Model Number: ESS305
• Device Lot Number: C68117
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 34 YR