MAUDE Adverse Event Report: N.V. ORGANON NEXPLANON IMPLANTED ROD (DEVICE); INSTRUMENT, SURGICAL, DISPOSABLE (KDC)

Lot Number U033390

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Failure of Implant (1924)

Event Date 08/10/2022

Event Type  malfunction  

Event Description

During retraction, implant "shot" out forcefully from needle it protruded from the other side of insertion site/device popped through her skin [device expulsion].During retraction, implant "shot" out forcefully from needle it protruded from the other side of insertion site and provider was able to "catch" the implant when it shot out of the opposite side of insertion.[complication of device insertion].Provider and medial assistant do feel the product was defective causing the implant to deploy too forcefully.[product quality issue].No additional ae [no adverse event].Case narrative: this solicited report has been received from a medical assistant referring to a 28-year-old female patient, who was enrolled in a patient support program entitled, "nexplanon benefit verification and rx triage"(also reported as customer support center for nexplanon (cscn)), conducted by lash.The patient's medical history and drug reactions/allergies were not reported.The patient's concomitant medication included etonogestrel implant (nexplanon).On (b)(6) 2022, the reporter stated that the patient presented for a routine removal and reinsertion.No complications were there with removal, no further details known regarding removal.On (b)(6) 2022 (same day), patient underwent an insertion procedure with etonogestrel implant (nexplanon) 1 implant of strength 68 milligrams (mg) in left arm (frequency was not reported) (lot# u033390 and expiration date was 03-jul-2024) for an unknown indication.During re-insertion, the reporter stated that the needle was inserted to its full length and slider was retracted.On (b)(6) 2022 (during retraction), implant "shot" out forcefully from needle it protruded from the other side of insertion site (device expulsion) and it was reported that the provider was able to "catch" the implant when it shot out of the opposite side of insertion (complication of device insertion).Provider and medical assistant felt that the product was defective (product quality issue) causing the implant to deploy too forcefully.A second device was not inserted at the time of report.Device and implant were available to retrieve.No additional adverse event (ae) (no adverse event) or product quality compliant (pqc) was reported, no additional information was known.It was reported that after insertion, the purple slider was unlocked and moved back fully until it stopped, and the applicator was kept in the same position within the arm during these steps.The unit did not appear defective in any way.There was no damage noticed on the carton, blister or unit prior to use.The needle was inserted in the arm to its full length.The implant was neither broken/cut or bent nor significant fibrosis.There was no incorrect, deep or multiple insertion.There was no insertion difficulty.There was no localization or migration problem.The outcome of the events device expulsion was considered to be recovered and complication of device insertion was considered to be not recovered.The reporter's causality assessment was not provided.Upon internal review, the event of device expulsion was considered to be medically significant.Follow up information was received on 29-aug-2022.The etonogestrel implant (nexplanon) with lot number u033390 was returned to manufacturer on 29-aug-2022.Follow up information was received from a physician on 29-sep-2022.The patient's current condition included connective tissue disease.On an unknown date, the patient's body mass index (bmi) was greater that (>) 30 (units not specified).The current implant was the patient's third implant.The second implant was inserted on an unknown date in 2019 and removed after 3 years of use.For the current implant the reporter did not use the same insertion channel as the previous.The reporter stated that, updated guidelines recommend more posterior location.Implant was inserted in left upper arm, which was a non-dominant arm, which was placed over the triceps muscle, approximately 3 inches from medial epicondyle of the humerus and approximately 1.5 inches posterior to the sulcus (groove) between the biceps and triceps muscles.The reporter stated that, after appropriately placing device in patient's arm, as per routine.The reporter placed gentle pressure at the insertion site to control the bleeding and the device popped through her skin at the most proximal position in the arm.Implant was not palpable just after the insertion and the reporter stated as "it literally popped out" and it was a complete expulsion.There was no problem with localizing the implant at insertion location.This was the final report.Executive summary: a manufacturing investigation for a adverse event quality investigation report (aeqir) from united states for etonogestrel implant (nexplanon) implanted rod (device) batch 0001341161, packaging lot u033390 was requested.A full investigation for lot u033390 was performed in accordance to qm-05267-doc and reviewed elements: logs, deviations review, review of previous corrective and preventive actions (capas), retention sample review, batch record review, release testing, component, raw material, and device component testing, change control review, stability results, and information regarding warehousing/distribution.Review of all batch specific data mentioned above did not identify any potential quality concerns.Additionally, review of release data confirmed that all specifications were met without deviations.The stability data for the product continues to meet all specifications.There were no deviations as a result of stability testing, none of which impacted product quality.Investigations for similar prior complaints for device expulsion have been received and were previously evaluated.Previous investigations have shown no indication of a potential quality issue.No prior capas or change controls were identified that caused an unintended impact to the quality of the product.Conclusion: no quality issues were observed during this investigation.The product as used was manufactured, packaged, stored and distributed in accordance with current good manufacturing practice (cgmp).As no quality issues were identified in this investigation, no capas are required.Manufacturing statement: a full investigation for lot u033390 was performed in accordance to qm-05267-doc and reviewed elements: logs, deviations review, review of previous capas, retention sample review, batch record review, release testing, component, raw material, and device component testing, change control review, stability results, and information regarding warehousing/distribution.Complaint sample not available for investigation.No potential quality issues were observed during this investigation.The product as used was manufactured, packaged, stored and distributed in accordance with cgmp.As no quality issues were identified in this investigation, no capas are required.Case comments: based on the clinically relevant information currently available for this individual case, and in accordance with the who causality assessment scale, the causal relationship is assessed as unlikely between the implanon nxt pharmacologic therapy (etonogestrel) and the reported events of device expulsion, complication of device insertion, product quality issue and no adverse event due to the lack of biological plausibility and human action/error may constitute a more plausible alternative explanation for the events.

• Brand Name: NEXPLANON IMPLANTED ROD (DEVICE)
• Type of Device: INSTRUMENT, SURGICAL, DISPOSABLE (KDC)
• Manufacturer (Section D): N.V. ORGANON; kloosterstraat 6; oss 5349 AB; NL 5349 AB
• Manufacturer (Section G): ORGANON & CO.; 30 hudson street; jersey city NJ 07302
• Manufacturer Contact: 30 hudson street; jersey city, NJ 07302
• MDR Report Key: 16322148
• MDR Text Key: 309510398
• Report Number: 3002806821-2023-00012
• Device Sequence Number: 1
• Product Code: KDC
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: U033390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2022
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/03/2021
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: NEXPLANON (ETONOGESTREL IMPLANT), IMPLANT.; NEXPLANON IMPLANTED ROD (DEVICE) (ETONOGESTREL IMP.
• Patient Outcome(s): Other
• Patient Age: 28 YR
• Patient Sex: Female
• Patient Weight: 133 KG