MAUDE Adverse Event Report: ABBOTT VASCULAR ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM; BIORESORBABLE SCAFFOLD

Catalog Number 1012460-18

Device Problem Patient-Device Incompatibility (2682)

Patient Problem No Information (3190)

Event Date 08/01/2015

Event Type  malfunction  

Manufacturer Narrative

Date of event: date is estimated.The absorb device was not commercially available in the u.S; however, it was similar to a device sold in the u.S.The scaffold remains in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Article study attached, titled 'very late strut overhang on coronary angioscopy after bioresorbable vascular scaffold implantation in a clinically stable patient'.

Event Description

Patient id: (b)(6).It was reported through an article that on (b)(6) 2013, the patient presented with exertional angina and a percutaneous coronary intervention was performed on the mid circumflex (cx), severely stenotic lesion.A 3.5x18mm bioresorbable vascular scaffold (bvs) scaffold was implanted without a device issue reported.Per optical coherence tomography, the scaffold was well apposed and well expanded on the vessel wall.In (b)(6) 2015, coronary angiography (cag) was performed which showed no restenosis.Optical coherence tomography (oct) displayed some scaffold discontinuities, however all struts were covered by the neointima.In (b)(6) 2016, cag was performed with no restenosis observed.Oct was performed and possible scaffold strut material was observed overhanging into the vascular lumen, at the proximal scaffold site.Subsequent coronary angioscopy showed that almost all of the remnant scaffold footprint was covered with whitish neointima, but the proximal parts were covered with heterogeneous patterned neointima.Furthermore, some material overhung into the lumen and was visible as a projecting filament with motion consistent with fluid flow currents.The patient was asymptomatic.Reportedly, the strut overhang did not result in adverse patient effect.There was no additional treatment and no hospitalization due to this issue.No additional information was provided regarding this issue.

Manufacturer Narrative

The device was not returned for evaluation.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no similar incidents from this lot.Based on the information reviewed, a conclusive cause for the reported patient-device incompatibility could not be determined; however, it is likely the reported scaffold discontinuities were the result of the scaffold resorption process which is expected by the design of the scaffold.There is no indication of a product quality issue with respect to manufacture, design or labeling.C4, actual therapy start date.D6, actual implant date.

Event Description

Subsequent to the previous medwatch report, the additional information was received: on 28-august-2013, the 3.5x18mm bioresorbable vascular scaffold (bvs) scaffold was implanted.

• Brand Name: ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM
• Type of Device: BIORESORBABLE SCAFFOLD
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11008904
• MDR Text Key: 225343173
• Report Number: 2024168-2020-10494
• Device Sequence Number: 1
• Product Code: PNY
• Combination Product (y/n): Y
• PMA/PMN Number: P150023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/17/2013
• Device Catalogue Number: 1012460-18
• Device Lot Number: 30522PA
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 73