MAUDE Adverse Event Report: AV-TEMECULA-CT ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM; BIORESORBABLE DRUG ELUTING SCAFFOLD

Device Problems Break (1069); Material Deformation (2976)

Patient Problems Pulmonary Embolism (1498); Hypersensitivity/Allergic reaction (1907); Occlusion (1984); Renal Failure (2041); Heart Failure (2206)

Event Date 06/14/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).An unspecified xience stent was implanted over the absorb scaffold for treatment.Iv hydration for kidney protection from contrast was provided and post procedure, water retention and severe bloating was noted.Immediately after discharge, the patient started to experience kidney failure.The patient was hospitalized from (b)(6) 2017 to (b)(6) 2017 for an unspecified reason.In (b)(6) 2017, two pulmonary embolisms were diagnosed and the patient was hospitalized for 3 weeks.The patient is pending a heart and kidney transplant.From (b)(6) 2017 to (b)(6) 2017, 5 stents were implanted.Per the physician, no additional heart catheterizations will be performed to protect the kidneys.No additional information was provided.The absorb scaffold remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The absorb device is currently not commercially available in the u.S; however, it is similar to a device sold in the us.Attachment: sus voluntary report# mw5077019.(b)(4).

Event Description

It was reported that via sus voluntary event report (#mw5077019) (b)(6) placed abbott dissolving stent in my husband, (b)(6) without our permission or knowledge prior to.We have attempted to find out health insurance company, (b)(6) approved this prior to.However, after raising concerns about this (b)(6) has begun to further ignore my husband's life-threatening issues.My husband was hospitalized twice immediately following the placement of this stent.His health has declined significantly since in (b)(6) 2017, (b)(6) started to experience a dry, persistent cough from (b)(6) 2017 and (b)(6) 2017 and (b)(6) 2017 and (b)(6) 2017, (b)(6) 2017 and (b)(6) was admitted to the hospital in heart and kidney failure.Most significant is that (b)(6) is a heart transplant recipient.(b)(6) had not experienced a raise in his creatinine level until immediately following the left catheterization on (b)(6) 2017, during which the surgeon discovered the stent had shifted and collapsed.We have raised our concerns about the use of this stent on a heart transplant recipient with (b)(6) and (b)(6) since (b)(6) and (b)(6) 2017.Subsequent information received states, the patient is a heart transplant recipient and has routine annual checkups to monitor for heart blockages.In (b)(6) 2016, a xience stent was implanted.On (b)(6) 2017, the absorb scaffold was implanted and remains in the patient anatomy.In (b)(6) 2017, a cough was noted and in (b)(6) 2017 allergy medication was prescribed.On (b)(6) 2017, a follow-up left heart catheterization was performed.The absorb scaffold was noted to be collapsed, shifted and fractured.

Manufacturer Narrative

(b)(4).The unique device identifier (udi) is unknown because the part and lot numbers were not provided.The device was not returned as it remains implanted.A review of the lot history record and complaint history could not be conducted because the part and lot numbers were not provided.The reported patient effects of hypersensitivity and occlusion as listed in the bioresorbable vascular scaffold (bvs) system, absorb, instructions for use are known adverse event associated with the use of a coronary scaffold in native coronary arteries.The investigation was unable to determine a conclusive cause for the reported migration of the scaffold, scaffold fracture or material deformation (collapsed scaffold) or a conclusive cause for the reported patient effects and the relationship to the product, if any.There is no indication of a product quality issue with respects to the design, manufacture or labeling of the device.

• Brand Name: ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM
• Type of Device: BIORESORBABLE DRUG ELUTING SCAFFOLD
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 7580228
• MDR Text Key: 110446957
• Report Number: 2024168-2018-04281
• Device Sequence Number: 1
• Product Code: PNY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,user facility
• Reporter Occupation: Patient
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR
• Patient Weight: 84