MAUDE Adverse Event Report: ABBOTT VASCULAR ABSORB; BIORESORBABLE SCAFFOLD

Catalog Number UNK ABSORB

Device Problems Product Quality Problem (1506); Material Too Rigid or Stiff (1544)

Patient Problems Angina (1710); Stenosis (2263)

Event Date 06/26/2019

Event Type  Injury  

Manufacturer Narrative

Date of implant, estimated.Exemption number (b)(4) permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The scaffold remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Na.

Event Description

It was reported that approximately 3 years post absorb bioresorbable vascular scaffold (bvs) implantation in the right coronary artery, the patient may have experienced angina.On (b)(6) 2019, optical coherence tomography (oct) was performed, and it was noted that the bvs had not yet been resorbed and restenosis was seen.Angioplasty was performed using a drug eluting balloon to treat the restenosis.No additional information was provided.

Manufacturer Narrative

D4: the unique device identifier (udi) is unknown because the part and lot numbers were not provided.The device was not returned for evaluation.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 angina and stenosis are listed in the bioresorbable vascular scaffold (bvs) system, absorb, instructions for use (ifu) as known adverse events associated with the use of a coronary scaffold in native coronary arteries.The investigation determined the reported complaint, additional treatment and hospitalization appear to be related to operational context.A conclusive cause for the reported patient effects and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.Device code 1506 - removed.

• Brand Name: ABSORB
• Type of Device: BIORESORBABLE SCAFFOLD
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 8857679
• MDR Text Key: 153167782
• Report Number: 2024168-2019-10543
• Device Sequence Number: 1
• Product Code: PNY
• Combination Product (y/n): N
• 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: 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK ABSORB
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention